Inspections in a Global Industry

Last November, the Oversight and Investigations subcommittee of the US House of Representatives' Energy and Commerce committee met to discuss the FDA's foreign drug inspection program. The opening statements of Chair Bart Stupak cited disturbing data and trends:

Increasing imports. Approximately 80% of active pharmaceutical ingredients in the US come from abroad. India and China account for more than half of these imports. India's pharmaceutical imports to the US have increased 2,400% from 1996 to 2006. China doubled its pharmaceutical imports to the US over the last five years.

Laura Bush

Lack of requirement for periodic foreign inspections. Federal law requires that US manufacturing sites be inspected every two years. No law specifies how often the agency must inspect foreign drug firms.

The FDA isn't sure how many foreign firms export to the US. Over three months, the FDA provided the subcommittee with a variety of counts of the foreign firms the agency needs to inspect—ranging from 2,100 to 13,800 foreign firms. (The agency's risk model counts about 3,300).

The agency's IT systems are woefully inadequate. As the agency's uncertainty about the number of foreign facilities indicates, the FDA needs an IT overhaul. The need for greater IT investment was also a major recommendation in the November 2007 report by the FDA Science Board.

Meanwhile, the number of FDA inspections is decreasing. The number of inspections carried out by CDER (in the US and abroad) dropped by 279 (to 2,411) from 2006 to 2005, and those conducted by CBER dropped by 126 (to 1,826), according to a March 2007 report from the FDA's Office of Regulatory Affairs. Information from the subcommittee meeting indicated that current resources allow foreign firms to be inspected only once every 12–13 years. And according to an October 31 Wall Street Journal article, the number of overseas inspectors is expected to drop in 2008 to 102, from 149 in 2002.

One way the agency is attempting to deal with this problem is by seeking cooperation from foreign governments such as China. Under an agreement signed last December, all Chinese companies that export certain drug products will have to register with Chinese regulators. The FDA will also gain access to Chinese inspection records, and the two countries will conduct joint training programs on inspection methods and other regulatory procedures.

Such efforts to strengthen cooperation with Chinese regulators are valuable, and given the FDA's insufficient resources, present a logical approach. But relying on Chinese regulators, who still have a long row to hoe to improve domestic regulation, is an interim measure at best.

FDA Commissioner Andrew von Eschbenbach has also said the agency would place staff in long-term assignments abroad, FDA News reported. This is another good step. Permanent offices abroad would be better, but resources for that are unlikely to appear anytime soon.

The agency has also proposed a reinspection user-fee system. Under this plan, facilities that fail to meet FDA requirements would have to pay for the full costs of reinspections and other follow-up work. Although such a system has some potential drawbacks—such as the risk that Congress would then decrease other funding to the agency—this is a worthwhile proposal.

Given how thin the FDA's resources are stretched, these approaches all make sense. The agency still needs to revamp its IT systems, though. This is critical, not just for inspections but for all of the FDA's mission.

Laura Bush is the editor in chief of BioPharm International, lbush@advanstar.com.